MAUDE Adverse Event Report: US ENDOSCOPY TRUFREEZE; CONSOLE

Model Number	CC3-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The patient was previously treated with endoscopic submucosal dissection (esd) and then radiofrequency ablation (rfa).Approximately three weeks after the patient was discharged from cryospray therapy, the patient later experienced bleeding.The patient sought treatment at the hospital, and the patient required one unit of blood transfusion, endoscopy with clipping of the esophageal ulcer and visible vessel.The catheter was not returned for evaluation.Without the return of the catheter the complaint cannot be confirmed, and the cause of the reported issue cannot be determined.The instructions for use (ifu 1500133) states the following: "when using a scope, place the catheter through the catheter introducer and into the biopsy or working channel of the scope.Ensure catheter and scope are completely defrosted before repositioning or withdrawing catheter.Withdraw catheter in the straight position.Care should be taken to avoid kinking or fracturing the catheter during handling and insertion into the catheter introducer." the instructions for use (ifu 1500509) states the following: "the physician should carefully consider patient eligibility for cryospray ablation (i.E., cryosurgery and associated gas pressure), including patient presentation, medical history, co-morbidities (e.G., copd, cad), and prolonged use of steroids that may reduce the patient's tissue compliance and tissue strength affecting their ability to tolerate cryospray." the log files were reviewed for the trufreeze console system and no issues were noted.No additional issues have been reported.

• Brand Name: TRUFREEZE
• Common Device Name: CONSOLE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5976 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 25116983
• Report Number: 1528319-2026-00047
• Device Sequence Number: 10249124
• Product Code: GEH
• UDI-Device Identifier: 00857068006006
• UDI-Public: (01)00857068006006
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CC3-01
• Device Catalogue Number: CC3-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown