truFreeze 20-00177Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00857068006099), received between Jan 5, 2018 and Feb 13, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Read Input Signal” (1 report).

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 18, 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.

• MalfunctionFeb 13, 2026Failure to Read Input Signal

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE MULTIPLE RAPID AV CATHETERS WOULD NOT SCAN WITH THEIR TRUFREEZE CONSOLE RESULTING IN A PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED USING A DIFFERENT MODALITY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333807 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT IS AN (B)(6) YEAR OLD MAN WITH ESOPHAGEAL ADENOCARINOMA. FULL THICKNESS PERFORATION OCCURRED AT THE GASTROESOPHAGEAL JUNCTION/PROXIMAL STOMACH WITHIN 5 SECONDS OF INITIATING CRYOSPRAY. A 16 FR CDT WAS USED. THE CONSOLE AND CATHETER APPEARED TO OPERATE NORMALLY. THE PERFORATION WAS RECOGNIZED IMMEDIATELY AND TREATED APPROPRIATELY. IF ENDOSCOPIC SUTURING WAS NOT AVAILABLE, THIS PATIENT WOULD HAVE REQUIRED EMERGENT LAPAROSCOPY/LAPAROTOMY AND SURGICAL REPAIR OF THIS PERFORATION. THE ONLY POSSIBLE LAPSE IN TREATMENT PROTOCOL WAS THE FAILURE TO ASSESS THE CDT FOR PROPER FUNCTION ONCE SUCTION WAS TURNED ON AND PRIOR TO INITIATION OF CRYOSPRAY. KINKING OF THE 16 FRENCH CRYO-DECOMPRESSION TUBE WAS NOTED AFTER THE PERFORATION OCCURRED BUT NOT SEEN PRIOR. THIS COULD HAVE DEVELOPED WITH SCOPE REMOVAL AND MAY NOT HAVE BEEN PRESENT DURING THE SPRAY. NO HIGH-PRESSURE ALARM ON THE SUCTION CIRCUIT OCCURRED DURING THE PROCEDURE. THERE DOES NOT APPEAR TO BE ANY OTHER POSSIBLE USER ERROR OR EQUIPMENT MALFUNCTION DURING THE PROCEDURE. THE RAPIDITY OF THE DISTENSION AFTER SUCH A SHORT SPRAY, AND DEVELOPMENT OF PERFORATION, IS UNUSUAL. THE PATIENT REQUIRED ICU LEVEL CARE AND HAD A PROLONGED H

  Patient problems: Injury; Internal Organ Perforation; Perforation

  MAUDE report 8815620 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS SOMEWHAT DIFFICULT TO SEDATE, AND HE WAS MOVING AROUND SOMEWHAT DURING THE PROCEDURE, EVEN PRIOR TO CRYOTHERAPY. THE TRUFREEZE DEVICE FUNCTIONED NORMALLY. A RAPID AV CATHETER AND CDT WAS USED. SEDATION DURING THE PROCEDURE WAS MIDAZOLAM 9 MG AND MEPERIDINE 100 MG. CO2 INSUFFLATION WAS USED THROUGHOUT THE ENTIRE PROCEDURE. NO OBVIOUS KINKING WAS NOTED IN THE TUBE DURING THIS PROCEDURE, AND NO ALARMS WERE SOUNDED BY THE TRUFREEZE DEVICE (INCLUDING HIGH PRESSURE ALERT WITH SUCTION). TWO SITES WERE TREATED WITH 2 X 20 SECOND SPRAYS. DURING THE 4TH SPRAY, INCREASED ABDOMINAL DISTENSION WAS NOTED BY THE MONITOR OF THE ABDOMEN AND TREATMENT STOPPED AT 15 SECONDS. BASED ON THE DISTENSION SEEN, AS WELL AS PATIENT TACHYCARDIA. THE CRYOTHERAPY PROCEDURE WAS HALTED. THE CATHETER AND TUBING WERE REMOVED FROM THE PATIENT, AND REPEAT EGD WAS PERFORMED. HYPEREMIC TISSUE CHANGES WERE SEEN AT THE GASTROESOPHAGEAL JUNCTION, BUT NO PERFORATION WAS SEEN. THE STOMACH DID APPEAR COLLAPSED, CONCERNING FOR PERFORATION. A PORTABLE ABDOMINAL RADIOGRAPH AFTER THE PROCEDURE SHOWED "IMPRESSIVE" PNEUMOPERITONEUM. THE PATIENT WAS SENT TO INTERVENTIONAL RADIOLOGY, WHERE A PERCUTANEOUS PERITONEAL DR

  Patient problems: Injury; Internal Organ Perforation; Perforation

  MAUDE report 8815578 ↗
• InjuryJan 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) FEMALE WITH FOUR YEAR HISTORY OF STAGE FOUR LUNG CANCER HAD BEEN PRESENTING FOR SEVERAL MONTHS WITH RESPIRATORY SYMPTOMS SECONDARY TO MALIGNANT NARROWING OF THE ENDOBRONCHIAL AIRWAYS. PHYSICIAN BROUGHT THE PATIENT TO BRONCHOSCOPY TO DILATE AIRWAYS AND DECIDED TO USE SPRAY CRYOTHERAPY TO AID IN THE DILATION. SUPPORT TEAM INADVERTENTLY BROUGHT THE DOCTOR A RAPID AV (RAV) CATHETER FROM STOCK RATHER THAN THE POLYMERIC. GIVEN THAT NO CSA REPRESENTATIVE WAS PRESENT FOR THE CASE, THIS MISUSE OF THE RAPID AV WAS NOT NOTED PRIOR TO USE. THE PHYSICIAN FOLLOWED PASSIVE VENTING TRAINING WITH A MEDICAL ASSISTANT MONITORING THE CHEST FOR EXPANSION. THE BRONCHOSCOPE REMAINED IN THE TRACHEA AT THE CARINA AND THE CATHETER/SPRAY WAS DIRECTED TO THE MALIGNANT STENOSIS WHICH BY THE PHYSICIAN'S DESCRIPTION WAS ABOUT 9 MM IN MAX DIAMETER. HOWEVER, THE AIRWAY DISTAL TO THE NARROWED OPENING WAS ALSO RESTRICTED DUE TO THE MALIGNANT DISEASE. APPROPRIATE DISCONNECTION OF THE RESPIRATORY CIRCUIT AND DEFLATION OF THE ENDOTRACHEAL CUFF ALONG WITH A LARGE DIAMETER ET TUBE WERE UTILIZED FOR ADEQUATE GAS EGRESS. THE FIRST TWO SPRAYS OF APPROXIMATELY 5 SECONDS OF FROST WENT WITHOUT MEDICAL ISSUES. ON THE T

  Patient problems: Bradycardia; Cardiac Arrest; Pneumothorax

  MAUDE report 7167426 ↗