truFreeze CD3-001 (REF C08407030501)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00857068006013), received between Aug 13, 2019 and Dec 2, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2022Failure to Fire; Failure to Fire

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE TRUFREEZE SYSTEM CATHETER AND SCOPE EXPERIENCED ICE BUILD-UP PREVENTING FLOW OF THE GAS INTO THE PATIENT RESULTING IN A PROCEDURE DELAY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15905625 ↗
• MalfunctionDec 2, 2022Failure to Fire; Failure to Fire

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE TRUFREEZE SYSTEM CATHETER AND SCOPE EXPERIENCED ICE BUILD-UP PREVENTING FLOW OF THE GAS INTO THE PATIENT RESULTING IN A PROCEDURE DELAY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15905295 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED PNEUMOTHORAX WAS DETECTED FOLLOWING A SPRAY CRYOTHERAPY PROCEDURE WHICH INCLUDED USE OF THE TRUFREEZE SYSTEM. CHEST TUBES WERE PLACED TO TREAT THE PNEUMOTHORAX AND THE PATIENT WAS LATER DISCHARGED.

  Patient problems: Pneumothorax

  MAUDE report 15029815 ↗
• InjuryAug 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, DURING A SCT PROCEDURE, A (B)(6) YEAR OLD FEMALE SUFFERING FROM STAGE 4 LUNG CANCER, EXPERIENCED A BILATERAL PNEUMOTHORAX. THE PROCEDURE WAS PERFORMED IN THE OR. AN 8.5 ET TUBE WAS BEING USED AND THE CUFF WAS DOWN THE PATIENT WAS OFF THE VENTILATOR AS PER PROTOCOL. THE TREATMENT SITE WAS ABOUT 1 CM BELOW THE CARINA. THERE WERE TWO LOCATIONS TO TREAT: ONE AT 1'OCLOCK IN THE FIELD OF VIEW AND ONE AT 4 O'CLOCK. THE SITES WERE RIGHT NEXT TO EACH OTHER AT THE SAME LEVEL. THE TREATING PHYSICIAN TARGETED THE 1 O'CLOCK SITE FOR THE FIRST SPRAY. A PNEUMOTHORAX WAS DETECTED. CHEST TUBES WERE INSERTED AND THE PATIENT RECOVERED FROM THE PNEUMOTHORAX. PRIOR TO THE PROCEDURE THE TREATING PHYSICIAN HELD A DISCUSSION ABOUT THE POTENTIAL FOR A PNEUMOTHORAX (DUE THE CONDITION OF THE LUNGS FROM THE STAGE 4 CANCER) WITH THE PATIENT AND THE FAMILY. THIS REPORT WAS ORIGINALLY SENT TO THE TEST SITE ON 21 DEC 2018.

  Patient problems: Pneumothorax

  MAUDE report 8889268 ↗