truFreeze CC3-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00857068006006), received between Dec 28, 2016 and Sep 23, 2026 — classified as 4 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (7 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  The user facility reported that during a patient procedure while utilizing the truFreeze Console System and truFreeze Aire PV Passive Venting Catheter, the patient experienced a bronchospasm and cough during the first two seconds of cryo initiation. The patient was treated with other modalities, and the procedure was completed successfully.

  Patient problems: Pneumothorax

  MAUDE report 50869163 ↗
• MalfunctionJun 5, 2026Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, A PATIENT WAS BEING TREATED FOR A RIGHT BRONCHUS INTERMEDIUS STENOSIS WHICH INCLUDED THE USE OF A TRUFREEZE CONSOLE SYSTEM AND SUSTAINED A CREPITUS IN THE THROAT AREA AND A PNEUMOTHORAX. THE PATIENT WAS TREATED, DISCHARGED, AND REPORTED TO BE FINE.

  Patient problems: Pneumothorax

  MAUDE report 25407167 ↗
• MalfunctionMay 21, 2026Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT A PATIENT EXPERIENCED "SIGNIFICANT PAIN" A MONTH AFTER A PROCEDURE INVOLVING A TRUFREEZE CONSOLE. THE PATIENT SOUGHT MEDICAL TREATMENT, HOWEVER NO MEDICAL TREATMENT WAS ADMINISTERED.

  Patient problems: Pain

  MAUDE report 25244244 ↗
• MalfunctionMay 15, 2026Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT A PATIENT'S LEFT LUNG COLLAPSED WHILE UNDERGOING A PROCEDURE TO TREAT LUNG STENOSIS WHICH INCLUDED THE USE OF TRUFREEZE CRYOSPRAY THERAPY RESULTING IN A PROCEDURE POSTPONEMENT. THE PATIENT DIDN'T RECEIVE ANY MEDICAL INTERVENTION AND WAS STABILIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183909 ↗
• MalfunctionMay 7, 2026Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT A PATIENT STARTED BLEEDING AFTER UNDERGOING A PROCEDURE TO TREAT A TUMOR WHICH INCLUDED USE OF TRUFREEZE CRYOSPRAY THERAPY. THE PATIENT RECEIVED ADDITIONAL MEDICAL INTERVENTION AND WAS DISCHARGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25116983 ↗
• MalfunctionApr 22, 2026Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT A PATIENT EXPERIENCED DIFFICULTY BREATHING FOLLOWING THE PROCEDURE WHICH UTILIZED THE TRUFREEZE CONSOLE AND TRUFREEZE AIRE PV PASSIVE VENTING CATHETER KIT.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 24955415 ↗
• MalfunctionApr 1, 2026Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, A PATIENT HAD A BLOOD CLOT FORM WHILE USING THE TRUFREEZE SYSTEM CONSOLE RESULTING IN A PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT HAS SINCE BEEN DISCHARGED.

  Patient problems: Hematoma

  MAUDE report 24758612 ↗
• MalfunctionMar 30, 2026Connection Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE SUCTION PUMP TO THEIR TRUFREEZE CONSOLE SYSTEM WAS NOT OPERATING PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713033 ↗
• MalfunctionMar 25, 2026Break

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THEIR LUMIFLEX 3-STAGE BALLOON DILATION CATHETER WAS UNABLE TO BE DEFLATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, FOLLOWING A SHORT DELAY AFTER USER FACILITY PERSONNEL REMOVED THE SCOPE AND BALLOON TOGETHER AND CUT THE CATHETER TO ALLOW IT TO BE FULLY EXTRACTED FROM THE WORKING CHANNEL. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688665 ↗
• MalfunctionMar 19, 2026Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT A PATIENT EXPERIENCED PAIN TWO DAYS FOLLOWING A PROCEDURE WHICH INCLUDED USE OF THE RAPID AV CATHETER KIT AND TRUFREEZE CONSOLE SYSTEM. THE PATIENT HAD A PERFORATION UNDERNEATH THEIR TUMOR AND RECEIVED A STENT. THE PATIENT HAS SINCE BEEN DISCHARGED.

  Patient problems: Perforation of Esophagus

  MAUDE report 24643634 ↗
• MalfunctionMar 12, 2026Suction Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE SUCTION PUMP AND PC PANEL TO THEIR TRUFREEZE CONSOLE TEMPORARILY STOPPED WORKING, RESULTING IN A SHORT PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578432 ↗
• MalfunctionFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT A PATIENT EXPERIENCED DISCOMFORT (GAS IN HER PERITONEAL CAVITY) FOLLOWING THE PROCEDURE WHICH UTILIZED A RAPID AV CATHETER KIT AND A TRUFREEZE CONSOLE SYSTEM.

  Patient problems: Discomfort

  MAUDE report 24457939 ↗
• MalfunctionJan 29, 2026Suction Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE SUCTION PUMP TO THEIR TRUFREEZE CONSOLE STOPPED WORKING RESULTING IN A SHORT DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24215404 ↗
• MalfunctionNov 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING A TRADE SHOW EVENT, A TRUFREEZE CONSOLE WAS USED ON TWO INDIVIDUALS TO ATTEMPT TO TREAT THE SKIN; IRRITATION WAS REPORTED AS A RESULT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 23572958 ↗
• MalfunctionJul 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT THEIR TRUFREEZE CONSOLE GENERATED A SUCTION ERROR DURING THEIR DAILY STARTUP PROCESS. PATIENT PROCEDURES WERE POSTPONED FOR THE DAY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22482366 ↗
• MalfunctionMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT FOLLOWING THE USE OF THEIR TRUFREEZE CONSOLE SYSTEM AND BALLOON DILATION THE DOCTOR OBSERVED A PERFORATION TO THE PATIENT'S ESOPHAGUS. THE PATIENT RECEIVED A STENT AND SUTURES.

  Patient problems: Perforation of Esophagus

  MAUDE report 22077897 ↗
• MalfunctionMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT A PATIENT EXPERIENCED ABDOMINAL PAIN FOLLOWING A PROCEDURE INVOLVING A TRUFREEZE CONSOLE. A CT SCAN WAS PERFORMED, AND NO PERFORATION WAS FOUND.

  Patient problems: Pain

  MAUDE report 21944704 ↗
• MalfunctionApr 17, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE USER FACILITY REPORTED THAT THEIR TRUFREEZE CONSOLE DISPLAYED A BLANK SCREEN WHEN THE CONSOLE WAS POWERED ON. AS A RESULT, THREE PROCEDURES WERE POSTPONED. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858622 ↗
• MalfunctionMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT A PATIENT DEVELOPED A PNEUMOTHORAX DURING A PROCEDURE WHILE UTILIZING THE TRUFREEZE SYSTEM CONSOLE. THE PATIENT RECEIVED A CHEST TUBE AND WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Pneumothorax

  MAUDE report 21586613 ↗
• MalfunctionJan 2, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT DURING AN ENDOSCOPIC PROCEDURE A PATIENT OBTAINED A GASTRIC PERFORATION WHILE BEING TREATED FOR GASTRIC ANTRAL VASCULAR ECTASIA INVOLVING USE OF THEIR TRUFREEZE CONSOLE. THE PROCEDURE WAS ABORTED AND THE PATIENT RECEIVED SURGERY FOR THE PERFORATION.

  Patient problems: Perforation

  MAUDE report 21054542 ↗
• MalfunctionDec 30, 2024Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT DURING USE OF THE TRUFREEZE CONSOLE, BELLY STIFFENING AND ADDITIONAL BLOOD WAS OBSERVED FROM THE PATIENT. ADDITIONAL MEDICAL INTERVENTION (SURGERY) WAS REQUIRED.

  Patient problems: Abdominal Distention

  MAUDE report 21034603 ↗
• MalfunctionDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A PERFORATION DURING A PATIENT PROCEDURE WHILE USING THEIR TRUFREEZE CONSOLE. THE PROCEDURE WAS ABORTED AND THE PATIENT HAD TO RECEIVE A CHEST TUBE FOLLOWING THE ABORTED PROCEDURE. THE PATIENT IS NOW HOME AND DOING WELL.

  Patient problems: Perforation

  MAUDE report 21020591 ↗
• MalfunctionNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT FOLLOWING TWO TRUFREEZE PROCEDURES, BOTH PATIENTS EXPERIENCED POST PROCEDURE DISCOMFORT. THE PATIENTS WERE BOTH READMITTED FOR ADDITIONAL CARE. AFTER A CT EVALUATION WAS CONDUCTED, A RIGHT PLEURAL EFFUSION WAS DETECTED IN BOTH PATIENTS. THE SECOND DAY FOLLOWING BOTH PROCEDURES, THE PATIENTS WERE DISCHARGED TO GO HOME WITH NO LASTING EFFECTS REPORTED. MEDICATION WAS ADMINISTERED TO BOTH PATIENTS FOLLOWING DISCHARGE. IT IS UNKNOWN WHAT TYPE OF MEDICATION WAS ADMINISTERED.

  Patient problems: Pleural Effusion

  MAUDE report 20678142 ↗
• MalfunctionOct 17, 2024Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED A SUBMUCOSAL TEAR WAS DETECTED IN A PATIENT WHILE UNDERGOING A PROCEDURE WHICH INCLUDED USE OF TRUFREEZE CRYOSPRAY THERAPY. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Laceration(s)

  MAUDE report 20470274 ↗
• MalfunctionOct 11, 2024Activation Problem; Activation Problem

  THE USER FACILITY REPORTED THAT THE TRUFREEZE CONSOLE SUCTION WOULD NOT PASS THE BUILT IN TEST RESULTING IN A PROCEDURE POSTPONEMENT. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20431223 ↗