MAUDE Adverse Event Report: US ENDOSCOPY TRUFREEZE; TRUFREEZE CONSOLE SYSTEM

Model Number	CC3-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
Through follow-up, steris learned that the patient was being treated for post-radiation stricture.A steris territory manager performed in-service training with the doctor subject of the reported event and learned that cryotherapy was administered in three locations with dosimetry of two sprays at twenty seconds each.Cryotherapy was administered successfully with no incident.The patient was then dilated in multiple stages with dilation balloons.During the last dilation, the doctor observed bleeding.The doctor investigated the area and located a perforation in the esophagus.Following the reported event, the doctor stated that a ct was administered to the patient and no free air was observed and no leak was found.The doctor stated that the perforation may have been a deep rent (mucosal tear).Steris is in the process of reviewing the trufreeze console system log files.The instructions for use provides the user with the following information: "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.Any therapy or procedure compromising the integrity of the tissue, specifically in or adjacent to the targeted ablation area.The physician should use caution when applying cryospray in any organ where stricture or collapse is likely.The physician should use caution when considering cryospray for this high-risk patient situation, specifically regarding the ability to vent or extract gas.Physicians should use caution in any procedure or anatomy where a restriction or obstruction interferes with the adequate venting or nitrogen as, resulting in increased gas pressure.During cryospray, the patient must be monitored for abdominal distention and cryospray must be stopped if the abdomen becomes distended, if using in the esophagus.Liquid nitrogen expands more than 700 times when changing from a liquid to a gaseous state.It is imperative for patient safety that adequate venting is used to remove gas created during cryospray." no additional issues have been reported.
Additional Manufacturer Narrative
The trufreeze console system log files were reviewed and confirmed the device was operating to specifications; no abnormalities were noted.No additional issues have been reported.

• Brand Name: TRUFREEZE
• Common Device Name: TRUFREEZE CONSOLE SYSTEM
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor 44060 ; 4404130648
• MDR Report Key: 22077897
• Report Number: 1528319-2025-00042
• Device Sequence Number: 8711403
• Product Code: GEH
• UDI-Device Identifier: 00857068006006
• UDI-Public: (01)00857068006006
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/17/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown