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Device Lab 17

Cryotherapy System

Cryotherapy System in the BMEssentia 3D Device Lab

One probe, placed freehand through the skin under imaging, and one gas channel behind it. The ice grows as a single ball around the active length, and everything about the treatment is decided by where that one probe went. There is nothing to overlap and no spacing to plan, so the whole of the geometry is a single choice made once with a needle in a hand.

Also called: Cryotherapy, Cryosurgery, Cryoablation. Arabic: نظام العلاج بالتبريد. Device Lab 17 of 69 in BMEssentia Medical City, 2 configurations.

Overview: the configurations

Single-probe percutaneous cryoablation under imaging guidance

One probe, placed freehand through the skin under imaging, and one gas channel behind it. The ice grows as a single ball around the active length, and everything about the treatment is decided by where that one probe went. There is nothing to overlap and no spacing to plan, so the whole of the geometry is a single choice made once with a needle in a hand.

Multi-probe array with overlapping isotherms

Several probes driven from a manifold, each on its own valve, placed to a template so the spacing is a designed number rather than an estimate. The ice from the probes becomes confluent and so, if the spacing is right, do the lethal isotherms, and a warming catheter protects the one structure nearby that must not freeze.

How it works: the main parts

What each part does, from the Cryotherapy System lessons in the 3D Device Lab.

Argon and helium cylinders and their yokes
Two steel cylinders standing in a yoke beside the console, chained at two heights, each with a handwheel on top and an outlet keyed so that it will only mate with its own regulator. One is marked argon and one helium.
Two-stage regulator and high-pressure supply line
A stainless body clamped to the cylinder outlet, with two round gauges on it and a handwheel underneath. The upper gauge reads what is left in the cylinder; the lower one reads what is being delivered to the console.
High-pressure circuit, filter and burst disc
Behind the cabinet wall: a tall filter canister with a drain at the bottom, a machined block carrying three solenoid coils, a stainless pipe run rather than hose, and a small brass housing on the side with a thin metal disc clamped inside it. The disc is the least impressive object in the assembly and it is the only part of the circuit guaranteed to fail before anything else does.
Counter-current heat exchanger
Inside the probe shaft, in the last five centimetres before the tip: a fine helix of tubing wound round a central line, sitting inside a return annulus. It is the part of this device that looks least like a refrigerator and it is the reason the device is one.
Joule-Thomson orifice and expansion chamber
A small plate across the gas path, near the base of the active length, with a hole in it sixty micrometres across. Downstream of it, a chamber the length of the tip.
Vacuum-jacketed probe shaft
A rigid steel needle, a couple of millimetres across, with ten-millimetre marks etched along it and a visible collar some way from the point. Everything on the hub side of that collar is a vacuum flask.
Freezing tip and active length
The bare metal at the end of the probe: a couple of centimetres of polished steel closed by a trocar point. It is the only part of this device that is a refrigerator, and its surface area is the single number the entire thermal calculation is built on.
Low-pressure return and exhaust
A fat corrugated hose from each probe hub back to a port low on the console, a silencer inside the cabinet, and a stack leaving the top of it. The hose is much fatter than the supply hose even though it carries exactly the same gas at exactly the same rate, and the reason it is fatter is the whole of what this component teaches.

Explore it in the Device Lab

Common faults and what to check

Most reported device problems (FDA MAUDE)

Device problemReports
Device Operates Differently Than Expected341
Appropriate Device Problem Term/Code Not Available225
Temperature Problem195
Excessive Cooling193
Break149
Thermal Decomposition of Device129

Raw counts of adverse event reports for this device type (FDA product code GEH), all years. Not adjusted for the number of units in use, so they show what gets reported, not failure rates. Report text is never copied.

Planned maintenance checks

From the BMEssentia procedure library: every 12 months, about 60 minutes, electrical class I, applied part type BF.

CheckPass when
Console, hoses and cylinders
Inspect the console, high-pressure hoses, regulators and cylinder restraints.
No damage; cylinders secured.
Electrical safety
Test to IEC 62353.
Within limits.
Gas pressure and probe test
Check supply pressure against the reference; run the manufacturer's freeze test.
Per manufacturer.
Room oxygen monitor
Expose the sensor to test gas.
Alarm at its set limit.

Test instruments: Gas pressure reference; Electrical safety analyser; Oxygen monitor test (room).

Recent FDA recalls

RecallProduct and reason
Z-0080-2027
2026-10-02
Limitless Cryo Spa LLC: Glypto Device, Glypto Cryo Machine
Lack of 510(k) clearance. Root cause: Under Investigation by firm.
Z-2938-2026
2026-08-12
Erbe USA Inc: ERBECRYO 2 Cryosurgical Unit
A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive. Root cause: Device Design.
Z-1566-2026
2026-03-20
Erbe USA Inc: Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm)
Probes may rupture/burst during activation Root cause: Process control.
Z-1567-2026
2026-03-20
Erbe USA Inc: Flexible Cryoprobe (OD 1.7mm, L1.15mm)
Probes may rupture/burst during activation Root cause: Process control.
Z-1568-2026
2026-03-20
Erbe USA Inc: Flexible Cryoprobe (OD 2.4mm, L1.15mm)
Probes may rupture/burst during activation Root cause: Process control.

From the FDA recall database (openFDA), newest first, imported 2026-10-22. 107 recalls on record for this device type. Recall text is the FDA's public text; each recall links to the official record.

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