truFreeze 2000181Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00724995199210), received between May 30, 2023 and Feb 4, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Break

  THE USER FACILITY REPORTED THAT THE WIRE OF THEIR ACTIVE VENTING CRYO DECOMPRESSION TUBE "POKED" THE PATIENT DURING A PATIENT PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER ACTIVE VENTING CRYO DECOMPRESSION TUBE. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261044 ↗
• MalfunctionNov 21, 2025Mechanical Problem; Mechanical Problem

  THE USER FACILITY REPORTED THAT THE GUIDEWIRE OF THE ACTIVE VENTING CRYO DECOMPRESSION TUBE WENT THROUGH THE SHEATH CAUSING A SMALL CUT TO THE PATIENT'S ESOPHAGUS. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED. THE PROCEDURE WAS CANCELLED AND RESCHEDULED FOR ANOTHER DAY.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 23622455 ↗
• MalfunctionJul 25, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE A STIFFENING WIRE, NORMALLY INTERNAL TO THE ACTIVE VENTING CRYO DECOMPRESSION TUBE, BECAME EXPOSED. AS A RESULT, THE PATIENT OBTAINED MUCOSAL DAMAGE IN THE UPPER ESOPHAGEAL SPHINCTER FROM THE EXPOSED WIRE. THE PATIENT WAS TREATED WITH A LIDOCAINE RINSE. THE PROCEDURE WAS DISCONTINUED AND RESCHEDULED AND COMPLETED SUCCESSFULLY AT A LATER DATE .

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 22612538 ↗
• MalfunctionApr 17, 2025Difficult to Advance; Difficult to Advance

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE TWO WIRES OF THEIR CRYO DECOMPRESSION TUBE WERE EXPOSED AND RESISTANCE WAS FELT BY USER FACILITY PERSONNEL WHILE OPERATING THE TUBE. USER FACILITY PERSONNEL ATTEMPTED TO STRAIGHTEN OUT THE WIRING OF THE TUBING BUT WERE UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY USING ANOTHER DEVICE. UPON COMPLETION OF THE PROCEDURE, CREPITUS WAS NOTICED ON THE BACK OF THE PATIENT'S NECK. MEDICAL TREATMENT WAS ADMINISTERED TO REMOVE THE CREPITUS; HOWEVER, IT IS UNKNOWN WHAT TYPE OF MEDICAL TREATMENT WAS ADMINISTERED.

  Patient problems: Crepitus

  MAUDE report 21857508 ↗
• MalfunctionJun 8, 2024Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT DURING A TRUFREEZE SPRAY CRYOTHERAPY PROCEDURE, WIRES INSIDE THEIR CRYO DECOMPRESSION TUBE LOOSENED AND BEGAN TO PULL OUT OF THE TUBE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19493596 ↗
• MalfunctionMay 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT A PERFORATION WAS DETECTED IN A PATIENT APPROXIMATELY THIRTEEN DAYS AFTER UNDERGOING A PROCEDURE WHICH INCLUDED USE OF TRUFREEZE CRYOSPRAY THERAPY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT SOUGHT AND RECEIVED ADDITIONAL MEDICAL INTERVENTION (ANTIBIOTICS, STENT).

  Patient problems: Perforation

  MAUDE report 17021843 ↗